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Evaluation of the Performance and Safety of a Type I Collagen-Based Medical Device (MD-Small Joints Collagen Medical Device) in the Treatment of Rhizarthrosis SMAGENART Pilot Study
Led by Guna S.p.a · Updated on 2025-01-17
42
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Collagen is a key structural protein in the body, especially found in skin, cartilage, bones, and joints. Researchers are evaluating an injectable medical device called MD-Small Joints Collagen Medical Device, which contains type I collagen from swine, to study its safety and performance in treating symptomatic thumb base osteoarthritis (rhizarthrosis). This condition causes joint pain and instability, and the study aims to see if the treatment can reduce pain and improve joint function. Participants will receive a series of five injections of the collagen device around and inside the affected thumb joint. The first three injections are given both inside and around the joint, while the last two are only around the joint. These injections are spaced weekly, starting at enrollment. The study is designed as a multicenter clinical investigation with assessments at baseline, 3 weeks, 6 weeks, and 16 weeks, with the final visit occurring 12 weeks after treatment ends. During the study, participants will be monitored closely with evaluations including pain measurement using the Visual Analogue Scale (VAS), functional assessments like the Disability of the Arm Shoulder and Hand (DASH) score, the Functional Index for Hand Osteoarthritis (FIHOA), and pinch strength tests. Researchers will also track analgesic use and any adverse events throughout the study. The main goal is to determine if the collagen treatment helps reduce pain by at least 30% six weeks after starting injections compared to baseline.
CONDITIONS
Brief Title
Evaluation of the Performance and Safety of a Type I Collagen-Based Medical Device (MD-Small Joints Collagen Medical Device) i the Treatment of RHIZOARTROSIS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female subjects aged between 18 and 75 years
- Clinically diagnosed symptomatic thumb carpometacarpal osteoarthritis confirmed by X-ray (stages I and II according to Eaton and Littler's classification)
- VAS pain score of 5 or higher during hand use
- Joint pain present for at least 1 month
- No use of thumb carpometacarpal orthotic devices
- Agreement not to take analgesics within 24 hours before study visits
- Ability to understand and sign informed consent
You will not qualify if you...
- Rheumatological conditions involving the hands
- Previous hand surgery for the affected pathology
- Hyaluronic acid injections in the thumb joint within the last 3 months
- Use of NSAIDs in the last 7 days or corticosteroids in the last 30 days
- Physical therapies (X-ray, Tecar, shock wave, laser, ultrasound) in the last 3 months
- Neoplastic diseases
- Systemic infections
- Uncontrolled diabetes
- Neurological conditions affecting study participation
- Coagulopathies or use of anticoagulants
- Immunosuppressive treatments
- Drug use or alcohol abuse
- Allergy to porcine collagen
- Pregnant or breastfeeding females
- Participation in other clinical studies during the same period
- Inability to cooperate or expected poor compliance
- Any condition judged by the investigator to warrant exclusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 weeks
Participants receive one infiltration of the collagen-based medical device at enrollment and then weekly for a total of 5 infiltrations to reduce pain and improve joint function in symptomatic thumb base osteoarthritis.
6 visits (1 at baseline and 5 weekly visits for infiltrations)
Duration - 11 weeks
Participants are monitored for safety and effectiveness of the treatment, including assessments of pain, joint function, and analgesic use up to 16 weeks after enrollment.
3 visits at 3 weeks, 6 weeks, and 16 weeks after enrollment
Trial Site Locations
Total: 1 location
1
ASST Grande Ospedale Metropolitano Niguarda Piazza dell'Ospedale Maggiore,
Milan, MI, Italy, 20135
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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